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CEUS for Blunt Abdominal Trauma in Children

Contrast Enhanced Ultrasonography for Blunt Abdominal Trauma Imaging in Children

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03490929
Enrollment
146
Registered
2018-04-06
Start date
2018-06-01
Completion date
2026-12-31
Last updated
2025-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Trauma Abdomen

Brief summary

Children with blunt abdominal trauma often get a CT as the first line imaging to evaluate for intra-abdominal organ injury. CT scans have some downsides with regard to radiation exposure, costs, and need for transport. Contrast enhanced ultrasonography has recently shown some promise as a way to detect intra-abdominal organ injury and may be able to replace the need for conventional CT scanning, without the need for ionizing radiation and the ability to be performed at the bedside.

Detailed description

In children with abdominal trauma, computed tomography (CT) of the abdomen is considered the gold standard for the initial evaluation of solid organ injuries. The major drawbacks to CT include risks due to radiation exposure and necessity of transport of the patient. Ultrasound without contrast uses safer non-ionizing radiation and can be performed at the bedside, however it has been shown to have variable sensitivity and specificity for identifying intra-abdominal organ injury. Newer studies using contrast enhanced ultrasound (CEUS) have shown promise for improving the sensitivity and specificity of this imaging modality. Hypothesis(es) and Aims: Hypothesis: Contrast enhanced ultrasound (CEUS) has good sensitivity and specificity as compared to a gold standard conventional CT scan for the identification of intra-abdominal solid organ injury in hemodynamically stable children with blunt abdominal trauma. Specific Aims: Primary Aim: To determine the test characteristics CEUS / conventional ultrasound for the detection of intra-abdominal solid organ injury, as compared to a gold standard CT scan, in hemodynamically stable children with blunt abdominal trauma Design: This will be a prospective cohort study to evaluate the test characteristics of contrast enhanced ultrasound (CEUS) for the detection of intra-abdominal solid organ injury in children with blunt abdominal trauma, as compared to a gold standard CT scan. Study subjects will be age 0-18 years, presenting with hemodynamically stable blunt abdominal trauma and for whom an abdominal CT scan is planned. The exclusion criteria will be a known allergy to the ultrasound contrast agent, co-existing penetrating abdominal trauma, or known congenital or acquired heart disease. Sample size calculations assume a baseline prevalence of disease in approximately 20% of patients receiving a CT scan, and target a sensitivity of at least 95% with a two-sided confidence interval precision of 8%, yielding an estimated sample size of 146 patients. The primary outcome will be calculation of sensitivity and specificity of CEUS as compared to a gold standard CT scan.

Interventions

DEVICEcontrast-enhanced ultrasound

ultrasound of the abdomen after injection of ultrasound contrast agent (Lumason)

Sponsors

Mayo Clinic
CollaboratorOTHER
Children's Hospital of Philadelphia
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
0 Years to 17 Years
Healthy volunteers
No

Inclusion criteria

1. Hemodynamically stable (defined as not needing massive transfusion protocol and not undergoing an emergent surgical procedure within the next hour) 2. History of or suspicion for blunt abdominal trauma 3. Abdominal CT ordered or obtained

Exclusion criteria

1. History of allergic reaction to Lumason, sulfur hexaflouride, sulfur hexafluoride lipid microsphere components, or other ingredients in Lumason (polyethylene glycol, distearoylphosphatidylcholine (DSPC), dipalmitoylphosphatidylglycerol sodium (DPPG-Na), palmitic acid) 2. Co-existing penetrating abdominal trauma 3. Known congenital or acquired heart disease

Design outcomes

Primary

MeasureTime frameDescription
Sensitivity of CEUSthrough study completion, which is expected to take around 3 yearscalculation of sensitivity of CEUS for organ injury, as compared to gold standard CT
Specificity of CEUSthrough study completion, which is expected to take around 3 yearscalculation of specificity of CEUS for organ injury, as compared to gold standard CT exam

Countries

United States

Contacts

Primary ContactAaron E Chen, MD
chena2@chop.edu2674260383
Backup ContactRachel Rempell, MD
rempellr@chop.edu2155907041

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026